Regulatory Affairs Executive

2 weeks ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**Headquartered: US**:

- **Position: Regional**:

- **Product Porfolio: Medical Devices**:

- **Reporting to: Regulatory Affairs Manager**

**MAIN RESPONSIBILITIES**:

- Facilitate regulatory affairs activities related to regulatory submissions, annual reports, registrations, and listings while ensuring compliance with relevant medical device regulations, guidances, and standards in applicable countries.
- Work with other departments to communicate regulatory submission requirements when documents are needed.
- Assist in preparing responses to regulatory authorities' questions within assigned timelines.
- Develop solutions to regulatory issues during pre-market activities and establish partnerships for effective implementation and resolution.
- Drive regulatory affairs and quality assurance activities to ensure timely registration of products and life cycle management while minimizing risks associated with post-marketing surveillance.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
- Keep up-to-date with changes in regulatory requirements in relevant countries by monitoring relevant regulatory changes.
- Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.
- Assist in the maintanence of the regulatory database, updating it regulatory and promptly as necessary.
- Overseeing the planning, coordination, and management of regulatory documentation activities

**REQUIREMENTS**:

- Bachelor's degree in a relevant field such as bioengineering or a related discipline.
- At least **1-2 years **' of experience in regulatory affairs in the medical devices industry.

**ESSENTIAL QUALITIES**:

- Problem-solving skills to navigate complex regulatory issues and find innovative solutions.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- Collaboration skills to work effectively with cross-functional teams, including commercial, manufacturing, and quality assurance.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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